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The Food and Drug Administration has granted Orphan Drug designation to ADXS-HPV, made by Advaxis, for the treatment of Stage II-IV invasive cervical cancer.

Orphan Drug Designation is granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the United States. The status then entitles the sponsor to clinical protocol assistance with the FDA, as well as annual grant funding, tax credits, waiver of PDUFA filing fees, and potentially a seven-year market exclusivity period.

A news release from the company notes that the immunotherapy, which previously had been granted Orphan Drug status for anal and head and neck cancers, is designed to target cells expressing the HPV gene E7. Such expression from high-risk HPV variants is responsible for the transformation of infected cells into dysplastic and malignant tissues. The theory is that eliminating these cells can eliminate the dysplasia or malignancy.

“ADXS-HPV is designed to infect antigen-presenting cells and direct them to generate a powerful, cellular immune response to HPV E7,” the news release said. “The resulting cytotoxic T cells infiltrate and attack the tumors while specifically inhibiting tumor Tregs and MDSCs [myeloid-derived suppressor cells] in the tumors that are protecting it.”

The company is now planning the registrational program for ADXS-HPV, which is also being evaluated in other HPV-associated cancers including a Phase 2 trial in advanced cervical cancer, a Phase 1/2 study in head and neck cancer, and a Phase 1/2 trial in anal cancer.